Treatment of Rheumatoid Arthritis with a Recombinant Human Tumor Necrosis Factor Receptor (p75)-Fc Fusion Protein

doi:10.1056/NEJM199707173370301

Volume 337:141-147		July 17, 1997		Number 3

Treatment of Rheumatoid Arthritis with a Recombinant Human Tumor Necrosis Factor Receptor (p75)–Fc Fusion Protein

Larry W. Moreland, M.D., Scott W. Baumgartner, M.D., Michael H. Schiff, M.D., Elizabeth A. Tindall, M.D., Roy M. Fleischmann, M.D., Arthur L. Weaver, M.D., Robert E. Ettlinger, M.D., Stanley Cohen, M.D., William J. Koopman, M.D., Kendall Mohler, Ph.D., Michael B. Widmer, Ph.D., and Consuelo M. Blosch, M.D.

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ABSTRACT

Background Tumor necrosis factor (TNF) is a proinflammatorycytokine involved in the pathogenesis of rheumatoid arthritis,and antagonism of TNF may reduce the activity of the disease.This study evaluated the safety and efficacy of a novel TNFantagonist — a recombinant fusion protein that consistsof the soluble TNF receptor (p75) linked to the Fc portion ofhuman IgG1 (TNFR:Fc).

Methods In this multicenter, double-blind trial, we randomlyassigned 180 patients with refractory rheumatoid arthritis toreceive subcutaneous injections of placebo or one of three dosesof TNFR:Fc (0.25, 2, or 16 mg per square meter of body-surfacearea) twice weekly for three months. The clinical response wasmeasured by changes in composite symptoms of arthritis definedaccording to American College of Rheumatology criteria.

Results Treatment with TNFR:Fc led to significant reductionsin disease activity, and the therapeutic effects of TNFR:Fcwere dose-related. At three months, 75 percent of the patientsin the group assigned to 16 mg of TNFR:Fc per square meter hadimprovement of 20 percent or more in symptoms, as compared with14 percent in the placebo group (P<0.001). In the group assignedto 16 mg per square meter, the mean percent reduction in thenumber of tender or swollen joints at three months was 61 percent,as compared with 25 percent in the placebo group (P<0.001).The most common adverse events were mild injection-site reactionsand mild upper respiratory tract symptoms. There were no dose-limitingtoxic effects, and no antibodies to TNFR:Fc were detected inserum samples.

Conclusions In this three-month trial TNFR:Fc was safe, welltolerated, and associated with improvement in the inflammatorysymptoms of rheumatoid arthritis.

Source Information

From the University of Alabama at Birmingham, Birmingham (L.W.M., W.J.K.); the Physician's Clinic of Spokane, Spokane, Wash. (S.W.B.); the Denver Arthritis Clinic, Denver (M.H.S.); Portland Medical Associates, Portland, Oreg. (E.A.T.); the Metroplex Clinical Research Center, Dallas (R.M.F., S.C.); the Arthritis Center of Nebraska, Lincoln (A.L.W.); Tacoma, Wash. (R.E.E.); and Immunex Corporation, Seattle (K.M., M.B.W., C.M.B.).

Address reprint requests to Dr. Moreland at the Arthritis Clinical Intervention Program, Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, 1717 6th Ave. S., Rm. 068, Birmingham, AL 35294-7201.

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Treatment of Rheumatoid Arthritis with a Tumor Necrosis Factor Receptor–Fc Fusion Protein
Epstein W. V., Mannik M., Wener M., Moreland L. W., Widmer M. B., Blosch C. M.
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N Engl J Med 1997; 337:1559-1561, Nov 20, 1997. Correspondence

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